Desloratadine in Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Desloratadine, mesalamine.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC), Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
Overview
The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.
Detailed description
Ulcerative colitis is a chronic inflammatory autoimmune disease affecting the colon. The World Health Organization has classified it as a relatively new treatment-resistant disease, and its prevalence has reportedly increased significantly in Egypt. A preclinical study was conducted to evaluate desloratadine as a potential therapeutic agent for ulcerative colitis, based on its known anti-inflammatory and antioxidant properties. The study concluded that desloratadine effectively alleviated experimental ulcerative colitis. This positive effect is attributed to its anti-inflammatory and antioxidant properties, which work by regulating mast cell activity and inhibiting histamine release.
Interventions
- Drug Desloratadine
mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months. - Drug mesalamine
mesalamine 1000 mg three times daily for 3 months
Primary outcome measures
- Change in disease activity and severity [Time frame: over a 3 month follow -up period]
Secondary outcome measures (1)
- Change in serum biomarkers [Time frame: Change from baseline in serum biomarker over 3 months]
Eligibility criteria
Inclusion criteria
- Both male and female sex.
- patients with age ranged from 18 to 65.
- patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
- Patients treated with 5-aminosalisylic acid (mesalamine).
Exclusion criteria
- Patients with severe UC
- Significant liver or kidney function abnormalities
- Pregnant or lactating females
- Treatment with systemic or rectal steroids
- Treatment with immunosuppressant or biological therapies
- Known allergy to desloratadine or any ingredient in the formulation
- Patients with other inflammatory diseases
- Patients with history of colon cancer
- Patients with complete or partial colectomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Menofia university Hospitals — Shibīn al Kawm
Identifiers
NCT: NCT07333716 · 12/2025 TRop1